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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K900684
Device Name RDW AND MPV INDICES ON HEMAT 12
Applicant
Texas Intl. Laboratories, Inc.
50 Sargent St.
Needham,  MA  02192
Applicant Contact ROBERT P COGAN
Correspondent
Texas Intl. Laboratories, Inc.
50 Sargent St.
Needham,  MA  02192
Correspondent Contact ROBERT P COGAN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/12/1990
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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